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OpenTrials
Completed

NCT Number: NCT03404128

Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy.

Endpoints:

* Long term evaluation of the effects of hippocampal DBS on seizure frequency and cognition * Evaluation of the satisfaction of patients and neurologist regarding the rechargeable DBS battery

Completed

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital

Exclusion criteria

  • (none)

Treatment and study plan

questionnaires

Other

Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery

Primary outcomes

  1. Seizure frequency per month based on seizure diary

    Time frame: Every six months (up to 2 years after implantation of rechargeable device)

    Efficacy measured by reduction in seizure frequency before and after implantation

Secondary outcomes

  1. Cognition

    Time frame: Yearly (up to 2 years after implantation of rechargeable device)

    Cognition measured by neuropsychological testing

  2. Number of device problems

    Time frame: Every six months (up to 2 years after implantation of rechargeable device)

    Reporting of device problems including long charging time, bad connection between device and charger, high frequency of charging (> 1 time a day).

  3. Number of adverse events

    Time frame: Every six months (up to 2 years after implantation of rechargeable device)

    Reporting of adverse events after implantation

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic

Registry information

Official study title

Long Term Follow-up of Patients Treated With Hippocampal Deep Brain Stimulation for Refractory Epilepsy

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2018
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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